A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
详细描述
Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between 18 and 56 years old;
- •Diagnosed with Autoimmune Diseases；
- •Good organ functions;
- •Voluntary participates this trial and can comprehend and sign ICF.
排除标准
- •Had or has active malignancy;
- •Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- •Combined with other autoimmune disease that needs treatment;
- •Pregnant or lactating women;
- •Has other factors that deemed not suitable by investigator.
研究组 & 干预措施
CAR-T treatment
干预措施: CAR-T (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 0~28 day after treatment
Frequency of AEs, SAEs
时间窗: 0 day to 24 months after treatment
次要结局
未报告次要终点